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Technical Quality Specialist, Regulatory Compliance
2 weeks ago
Our team members are truly centred around our customers, and we know that behind every lab requisition, sample being tested, or investment in technology is an individual and their family counting on us.
Consistently named one of Canada's Best Employers by Forbes, LifeLabs has also been recognized for having an award-winning Mental Health Program from Benefits Canada.
The passion and commitment of over 6,000 diverse and innovative team members unites and motivates us to ensure our customers receive high quality tests and results that they can trust.
Agile, customer-centred, caring and teamwork: we live these values every day in what we do to support our customers and healthcare providers, driving forward our vision of _empowering a healthier you_.
Make a difference - join the LifeLabs team todayCore Accountabilities
- Support external assessments, including preparation of preassessment submissions, scheduling, and postassessment documentation
- Support maintenance of records of external regulatory assessments (for example: DAP and ACD)
- Provide technical, quality assurance/quality systems and troubleshooting support for operations as required
- Ensure operational policies, processes, procedures, job aids and forms remain current with applicable regulations, legislation and best practice
- Support the internal audit process and collaborate with stakeholders to develop and implement corrective actions
- Provide support to Medical/Scientific, Operations, Business Development, IT, Billing, EHS and other support departments as required
- Observes and executes all safety and security policies and regulations
- Other duties as required
Minimum Qualifications and Skills
- College Diploma in Medical Laboratory Technology or equivalent education and experience
- Must have CSMLS certification
- Medical Laboratory Technologist
- Minimum of 5 years previous disciplinespecific laboratory experience
- Strong Technical and Quality Systems knowledge and understanding, to provide expert technical support to all customers, internal and external
- Proven ability to facilitate compliance with the Quality Management System within a regulated environment
- A clear understanding of regulatory enforcement procedures and the business impact of failing to meet external regulatory requirements
- Facilitation skills necessary to lead discipline specific teams, and the confidence and/or training to conduct internal audits
- The ability to use sound risk management analysis to assess the regulatory and business impact of prioritizing goals
- Excellent verbal communication skills to effectively communicate decisions and seek input
- Excellent technical writing skills to create and maintain documentation
- Strong organizational, change and project management skills to ensure that deliverables are achieved on schedule in a controlled manner
- Occasional travel required
At LifeLabs, we strive to create an inclusive and equitable workplace where our team members and the communities we serve feel accepted, valued, and respected.
We have been a leader throughout the COVID-19 pandemic regarding health and safety measures and have always put our employees and customers at the center of every decision that we make.
As an organization in the health care sector, we believe the COVID vaccination adds a layer of protection that complements the extensive and necessary health and safety protocols that we have taken to date.
With this in mind, we currently require all LifeLabs employees, contractors, students and volunteers to be fully vaccinated.LifeLabs operates under a distributed workforce model, where employee flexibility is a key priority. Further information will be provided during the interview process on what this means for employees.
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